Senior Clinical Trial Manager, PKU
1 week ago
At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Manager (Sr. CTM) at Maze Therapeutics, you'll play a hands-on role in driving the execution of our clinical trials. You'll have the opportunity to lead early- to mid-stage clinical studies, work cross-functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards. If you enjoy taking initiative, working in a fast-paced environment, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you.
The Impact You'll Have
- Clinical Trial Execution & Leadership
- Co-lead operational activities of a mid-stage clinical trial, ensuring high-quality execution from study design to completion. Manage a Study Execution Team (SET) alongside the Study Lead, from protocol development to completion of key study milestones (FPI, enrollment completion, interim analysis, database lock, and final CSR).
- Maintain active, hands-on oversight of CRO operations by closely tracking study progress, evaluating risks, and intervening early to course-correct.
- Apply a solution-oriented mindset to optimize study processes, boost study recruitment, and strengthen vendor/site performance.
- Vendor, CRO & Site Management
- Provide strategic sponsor oversight of the global CRO monitoring team, guiding the CRO Global CTM and CRAs to ensure alignment with study timelines, recruitment targets, and high-quality data delivery. Initiate methods to better build relationships with sites, address issues, and ensure on-track enrollment and data entry.
- Lead end-to-end vendor management for all clinical trial vendors, including vendor identification and selection, budget and contract negotiations, onboarding, and ongoing operational oversight, ensuring compliance with study protocols, contracted scope, and ICH-GCP requirements.
- Develop and manage study-specific plans including site monitoring strategies, blinding plan, etc. Experienced in organizing DMCs, managing clinical trial budgets, and review clinical data listings and summary tables.
- Budget & Financial Oversight
- Support Clinical Operations Leadership with study-specific budget tracking and vendor spend management.
- Data Quality, Compliance & Regulatory Readiness
- Ensure clinical trial data integrity and adherence to protocols, SOPs, and ICH-GCP guidelines through oversight of CROs, vendors, and site monitoring activities.
- Partner with Quality Assurance on inspection readiness efforts.
- Process Optimization & Technology Implementation
- Contribute to evaluating and implementing clinical trial systems (e.g., eTMF, CTMS, RBM) to enhance efficiency.
- Assist in developing SOPs and scalable processes for clinical operations.
- Cross-functional Collaboration
- Partner with cross-functional teams like Biostatistics and Clinical science to identify and onboard new study vendors and systems (e.g. ARGUS).
- Partner with internal teams, such as CMC and Clinical Supply Chain, to manage study drug supply and distribution. Work closely with other functions to ensure smooth study execution.
- A Bachelor's degree in a scientific discipline or health related field with 5-8 years of clinical operations experience, including at least 4 years as a CTM, with hands-on experience managing Phases I-III clinical trials. Global trial experience is a plus.
- Experience in common disease and/or rare disease drug development.
- Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP)
- Experience conducting a broad range of clinical trial related activities including study start-up to study close-out, clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of clinical trial budgeting, and managing CROs and vendors.
- Strong executional leadership, problem-solving skills, and ability to manage cross-functional teams at the study level.
- A startup mindset, willingness to roll up sleeves, and ability to work in a fast-paced, evolving, and collaborative team environment.
- Excellent communication skills and the ability to manage cross-functional relationships effectively.
- Are willing to travel up to 30% to support study needs.
Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco.
Our People
Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
Our Core Values
Further Together - Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission.
Impact Obsessed - We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.
Stand True - Our integrity is foundational; it guides us no matter the obstacle.
The expected annual salary range for employees located in the San Francisco Bay Area is $176,000 - $215,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.
Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.
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